NCT_ID: NCT05967130
Clinical Trial Link
Brief Summaries
| Sequence: | 30582947 |
| Description | Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs. |
Studies
| Study First Submitted Date | 2023-07-15 |
| Study First Posted Date | 2023-08-01 |
| Last Update Posted Date | 2023-08-01 |
| Start Month Year | July 1, 2023 |
| Primary Completion Month Year | January 1, 2024 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-08-01 |
Detailed Descriptions
| Sequence: | 20599031 |
| Description | According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy. |
Facilities
| Sequence: | 198798128 |
| Status | Recruiting |
| Name | Nooshin Dalili |
| City | Tehran |
| Zip | 1666663421 |
| Country | Iran, Islamic Republic of |
Facility Contacts
| Sequence: | 27964226 |
| Facility Id | 198798128 |
| Contact Type | primary |
| Name | Nooshin Dalili, Dr |
| nooshindalili4@gmail.com | |
| Phone | 00989122404331 |
Conditions
| Sequence: | 51856985 | Sequence: | 51856986 |
| Name | Urinary Tract Infections | Name | Transplant-Related Disorder |
| Downcase Name | urinary tract infections | Downcase Name | transplant-related disorder |
Id Information
| Sequence: | 39906948 |
| Id Source | org_study_id |
| Id Value | SBMU- |
Countries
| Sequence: | 42304897 |
| Name | Iran, Islamic Republic of |
| Removed | False |
Design Groups
| Sequence: | 55284425 |
| Group Type | Experimental |
| Title | UC Positives |
| Description | Stable Transplanted Patients with Positive UC |
Interventions
| Sequence: | 52177219 |
| Intervention Type | Biological |
| Name | Phage |
| Description | Inserting specific specimen of phages in to the bladder |
Design Outcomes
| Sequence: | 176358368 |
| Outcome Type | primary |
| Measure | Urine culture |
| Time Frame | 1 week after administration |
| Description | Negative Urine Culture |
Browse Conditions
| Sequence: | 192215866 | Sequence: | 192215867 | Sequence: | 192215868 | Sequence: | 192215869 | Sequence: | 192215870 | Sequence: | 192215871 | Sequence: | 192215872 |
| Mesh Term | Infections | Mesh Term | Urinary Tract Infections | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases |
| Downcase Mesh Term | infections | Downcase Mesh Term | urinary tract infections | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48028567 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Shahid Beheshti University of Medical Sciences |
Overall Officials
| Sequence: | 29102560 |
| Role | Principal Investigator |
| Name | Dalili |
| Affiliation | SBMU |
Central Contacts
| Sequence: | 11943946 |
| Contact Type | primary |
| Name | Dalili |
| Phone | 00989122404331 |
| dr.nooshindalili@gmail.com | |
| Phone Extension | 0098 |
| Role | Contact |
Design Group Interventions
| Sequence: | 67772358 |
| Design Group Id | 55284425 |
| Intervention Id | 52177219 |
Eligibilities
| Sequence: | 30581728 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Stable Kidney Transplant Recipients Stable Immunosupression Dose Stable Renal Function Resistant Urinary Infection with Positive UC Exclusion Criteria: Rejection periods Frail Patients |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 253855626 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Number Of Primary Outcomes To Measure | 1 |
Designs
| Sequence: | 30329893 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28708683 |
| Responsible Party Type | Principal Investigator |
| Name | nooshin dalili |
| Title | Assistant Professor |
| Affiliation | Shahid Beheshti University of Medical Sciences |